FDA Registration
Active
🇺🇸 United States
Pacel Bipolar Pacing Catheter 401765, 401775, 401766, 401776, 401767, 401768, 401769, 401770, 401771, 401772, 401773
Reg #: 3013288201
·
FEI: 3013288201
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABBOTT MEDICAL
- Registration Number
- 3013288201
- FEI Number
- 3013288201
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14901 Deveau Pl. Building 2
- City
- Minnetonka
- State
- MN
- ZIP
- 55345
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152784
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 2021-02-05 |
Proprietary Names
Pacel Bipolar Pacing Catheter 401765, 401775, 401766, 401776, 401767, 401768, 401769, 401770, 401771, 401772, 401773
Establishment Types
Manufacture Medical Device